Johnson & Johnson's faulty hips

Swinging all the way to the courtroom

MOST companies do everything they can to keep their executives away from court. A case in California helps to demonstrate why. Johnson & Johnson faces more than 10,000 lawsuits over artificial hips it produced that shed metal debris inside patients. The case is the first to go to trial and provides gripping television, available on the Courtroom View Network. Lawyers are assailing company employees with accusations (“You knew that cobalt chromium is cyto-toxic to human cells, right?” was a typical question.) J&J is less enthralled.

The company’s subsidiary, DePuy, launched the ASR hips (pictured above) in America in 2005 and recalled them five years later. At that time there were more than 93,000 hips on the market, with 37,000 in the United States. DePuy now faces questions about what it knew about the hips’ problems and whether it hid that information from consumers. (Documents supporting the plaintiff's opening statement can be read here.)

The plaintiff’s lawyer, Michael Kelly, has argued that DePuy should have conducted further studies before putting the product on the market. Internal e-mails show that the company was receiving complaints about ASRs in 2005 and 2006. A study in 2007 by Chris Hunt, an engineer, explained how the ASR’s exaggerated angle could cause excessive wear. The study was not made public. Mr Kelly questioned Graham Isaac, a DePuy engineer, about those findings on February 4th.

“You need to tell the surgeon everything you know about the safety ramifications of the device, correct?” the lawyer asked Mr Isaac.

“Well, everything we think is relevant,” Mr Isaac responded.

“Well doctor, it’s not up to you to choose what’s relevant, is it?”

“I think it is to a certain extent it is, yes.”

In April 2008 Mr Isaac wrote to his colleagues at DePuy, including Andrew Ekdahl, who is now the firm’s president. He had new data comparing the release of metal ions from the ASR with that of a competitor’s product, the BHR. The data found that “under certain conditions ASR is susceptible to extreme metal ion levels, whereas in the hands of the same surgeon BHR does not have the same problems…I believe that this data will appear in the journals…and has the potential to seriously affect our business. We need to discuss this at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested.”

Asked about this in court, Mr Isaac insisted that, “We were making an improvement not correcting a defect”. Rather than alert consumers to the problems, another DePuy employee wrote, in May 2008, that “We will ultimately need a cup redesign but the short term action is manage perceptions.” The redesign never happened. DePuy decided to phase out sales in November 2009. The recall came later, in August 2010. Mr Ekdahl’s video testimony was shown to jurors on January 31st. He did not admit the product was unsafe.

More than 7,000 consolidated cases are due to go to trial in May in a federal court in Ohio. The case in California continues.

My grandfather got a hip replacement n the mid 80's and lived 25 more years without any complications. I just do not comprehend how these newer designs and materials and methods have a worse outcome.

Let it be known that I support tort reform and broad tort reform much like the gun industry has. But just think about the weeks sometime months of pain and recovery time when a hip joint is replaced then consider that a second time is much worse let alone complications from metal filings and ions in biological tissues.

Ethically it is more than justified that heads need to roll. If whatever warning signs didnt seem important then your thinking was wrong. This isnt one of those procedures where it is all or nothing and the patient needs to accept that risk. It isnt even like birth where once in a great while it just turns out wrong and you get a regrettable but not always preventable palsy. NOT AT ALL. These problems are from a procedure that was trouble free.

I'm not sure we see a smoking gun anywhere at this point. No doubt the best hip replacement out there continues to have problems reported about it. Taking the good from the bad field reports and making the jump to the decision that you should recall the product are two separate activities. I don't think they have been vindicated but I haven't seen anything to show that they knew the hip should be recalled but didn't do it.

As a Johnson and Johnson stock holder, I am ashamed of the course of action as initially portrayed in this article taken by a subsidiary they control. Too many other occurrences by other Johnson and Johnson affiliates in the past three years shine a bright light on mismanagement and corporate moral failings and ineptitude. Johnson and Johnson was once a fine example of how a corporation should handle a problem - Tylenol bottles with poisoned pills added to bottles on store shelves back in the 80's.
They reacted quickly and in an exemplary manner then. They have lost their core principals and have dirtied their name.

Knowing that they are selling a product which they knew would fail and after getting complaints from not only the US but many other countries. They continued to sell the product and not inform doctors of this problem. I think that's a big ethics problem.

They could of at least offered to tell the doctors not to implant them until they do further studies. In fact after the FDA told them to respond to all these complaints, they decided to sell their inventory off and then phase it out quickly.

Just a week ago they had emails and testimony that the ion filling was not from their product and it was b/c of diseases that these people had. But now these emails and testimony shows that their product infact was the reason for high level of mental content in the blood.

How very sad! They just continue to talk about how to phase the product out quietly over the years, yet they continue to let people go under surgeries knowing they will need to get them redone.

Do they realize how painful these surgeries are, how much $ it costs the person, recovery time, and only to find out that 6 months or a 2 years later they have to go through it all again b/c the company was trying to make an extra buck.